DATA AND SAFETY MONITORING The Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for the oversight and monitoring of clinical trials to ensure the: 1. Safety of patients; and 2. Validity and integrity of the data collected on these trials. Responsibility for data and safety monitoring at Thomas Jefferson University (TJU) resides in: 1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review of all new and ongoing cancer-related clinical trials within the KCC; 2. The Clinical Research Management Office (CRMO) which provides strategic assistance and support to the CCRRC, DSMC, and continuous monitoring; 3. The Institutional Review Board (IRB) which has primary responsibility for the protection of the welfare of human subjects involved in biomedical and behavioral research. The IRB has full authority to approve, request modifications prior to approval, disapprove, suspend, or terminate for cause all research activities that fall within its jurisdiction; and 4. The Data and Safety Monitoring Committee (DSMC), which is responsible for data and safety monitoring of Kimmel Cancer Center investigator-initiated trials (KCC IIT).